WO2021011408A1 - Tubing with integrated optical fiber, medical devices, and methods thereof - Google Patents
Tubing with integrated optical fiber, medical devices, and methods thereof Download PDFInfo
- Publication number
- WO2021011408A1 WO2021011408A1 PCT/US2020/041692 US2020041692W WO2021011408A1 WO 2021011408 A1 WO2021011408 A1 WO 2021011408A1 US 2020041692 W US2020041692 W US 2020041692W WO 2021011408 A1 WO2021011408 A1 WO 2021011408A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tubing
- integrated
- integrated tubing
- lumens
- lumen
- Prior art date
Links
- 239000013307 optical fiber Substances 0.000 title claims abstract description 66
- 238000000034 method Methods 0.000 title claims abstract description 17
- 239000011324 bead Substances 0.000 claims abstract description 85
- 238000004519 manufacturing process Methods 0.000 claims abstract description 7
- 238000001816 cooling Methods 0.000 claims description 9
- 210000003484 anatomy Anatomy 0.000 claims description 7
- 238000005520 cutting process Methods 0.000 claims description 3
- 230000003247 decreasing effect Effects 0.000 claims description 3
- 239000000463 material Substances 0.000 claims description 3
- 230000001360 synchronised effect Effects 0.000 claims description 3
- 229920000620 organic polymer Polymers 0.000 description 8
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 4
- 238000006073 displacement reaction Methods 0.000 description 4
- 229920001296 polysiloxane Polymers 0.000 description 3
- 229920002635 polyurethane Polymers 0.000 description 3
- 239000004814 polyurethane Substances 0.000 description 3
- 230000006978 adaptation Effects 0.000 description 2
- 238000011976 chest X-ray Methods 0.000 description 2
- 238000005253 cladding Methods 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 229920000592 inorganic polymer Polymers 0.000 description 2
- 230000005865 ionizing radiation Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 210000002620 vena cava superior Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00064—Constructional details of the endoscope body
- A61B1/0011—Manufacturing of endoscope parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00147—Holding or positioning arrangements
- A61B1/00148—Holding or positioning arrangements using anchoring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
- A61B1/07—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
- A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/001—Combinations of extrusion moulding with other shaping operations
- B29C48/0022—Combinations of extrusion moulding with other shaping operations combined with cutting
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/05—Filamentary, e.g. strands
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
- B29C48/11—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels comprising two or more partially or fully enclosed cavities, e.g. honeycomb-shaped
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/15—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor incorporating preformed parts or layers, e.g. extrusion moulding around inserts
- B29C48/154—Coating solid articles, i.e. non-hollow articles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/30—Extrusion nozzles or dies
- B29C48/32—Extrusion nozzles or dies with annular openings, e.g. for forming tubular articles
- B29C48/34—Cross-head annular extrusion nozzles, i.e. for simultaneously receiving moulding material and the preform to be coated
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
- B29C48/885—External treatment, e.g. by using air rings for cooling tubular films
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
- B29C48/919—Thermal treatment of the stream of extruded material, e.g. cooling using a bath, e.g. extruding into an open bath to coagulate or cool the material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/004—Multi-lumen catheters with stationary elements characterized by lumina being arranged circumferentially
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2011/00—Optical elements, e.g. lenses, prisms
- B29L2011/0075—Light guides, optical cables
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7542—Catheters
Definitions
- a tip of the peripherally inserted central catheter (“PICC”) or central venous catheter (“CVC”) can move becoming displaced from an ideal position in a patient’s superior vena cava (“SVC”).
- SVC superior vena cava
- a clinician believing such a PICC or CVC has displaced typically checks for displacement by chest X-ray and replaces the PICC or CVC if necessary.
- X-rays expose patients to ionizing radiation. Therefore, there is a need for clinicians to easily and safely check for displacement of PICCs and CVCs for replacement thereof if necessary.
- integrated tubing including, in some embodiments, a tubing wall, one or more lumens, and a longitudinal bead of the integrated tubing including one or more optical fibers disposed therein.
- Each lumen of the one or more lumens is defined at least in part by the tubing wall.
- the longitudinal bead of the integrated tubing is between opposing sides of the tubing wall.
- the integrated tubing has one lumen.
- the longitudinal bead is incorporated into the tubing wall.
- the integrated tubing has two or more lumens.
- each lumen of the two or more lumens has approximately a same volume as another lumen of the two or more lumens in an arbitrary length of the integrated tubing. [0009] In some embodiments, at least one lumen of the two or more lumens has a different volume than another lumen of the two or more lumens in an arbitrary length of the integrated tubing.
- the integrated tubing further includes one or more septa of the integrated tubing.
- Each lumen of the two or more lumens is further defined at least in part by the one or more septa.
- the longitudinal bead is incorporated into the tubing wall.
- the longitudinal bead is incorporated into at least one septum of the one or more septa.
- the longitudinal bead is incorporated into each septum of the one or more septa.
- the longitudinal bead has one optical fiber disposed therein.
- the longitudinal bead has a bundle of optical fibers disposed therein.
- the integrated tubing is bump tubing.
- the catheter tube includes a catheter-tube wall and one or more lumens of the catheter tube. Each lumen of the one or more lumens is defined at least in part by the catheter-tube wall.
- the integrated stylet includes one or more optical fibers.
- the catheter tube also includes a longitudinal bead between opposing sides of the catheter tube having the one or more optical fibers disposed therein.
- the catheter tube has one lumen.
- the longitudinal bead is incorporated into the catheter- tube wall.
- the catheter tube has two or more lumens. [0021] In some embodiments, each lumen of the two or more lumens has approximately a same volume as another lumen of the two or more lumens in an arbitrary length of the catheter tube.
- At least one lumen of the two or more lumens has a different volume than another lumen of the two or more lumens in an arbitrary length of the catheter tube.
- the medical device further includes one or more septa of the catheter tube.
- Each lumen of the two or more lumens is further defined at least in part by the one or more septa.
- the longitudinal bead is incorporated into the catheter- tube wall.
- the longitudinal bead is incorporated into at least one septum of the one or more septa.
- the longitudinal bead is incorporated into each septum of the one or more septa.
- the longitudinal bead has one optical fiber disposed therein.
- the longitudinal bead has a bundle of optical fibers disposed therein.
- a distal-end portion of the catheter tube has a smaller diameter than a proximal-end portion of the catheter tube.
- the distal-end portion of the catheter tube configured to interface with a patient’s anatomy.
- the proximal-end portion of the catheter tube is configured to interface with procedural equipment or instrumentation.
- the medical device is a PICC or a CVC.
- Also disclosed herein is a method for manufacturing integrated tubing including, in some embodiments, threading at least one optical fiber through a die of an extruder; forcing a molten polymeric material through the die around the optical fiber to form the integrated tubing with the optical fiber disposed within a longitudinal bead of the integrated tubing; and cooling the integrated tubing in a cooling bath by pulling the integrated tubing through the cooling bath with a puller.
- the method further includes coiling the integrated tubing onto a spool of the integrated tubing with a coder.
- a rate of pulling the integrated tubing with the puller is increased to create portions of the integrated tubing with a smaller diameter or decreased to create portions of the integrated tubing with a larger diameter.
- the method further includes cutting the integrated tubing into predetermined lengths of the integrated tubing with a cutter.
- the cutter is synchronized with the puller such that each predetermined length of the integrated tubing includes a first-end portion of the predetermined length having a smaller diameter than a second-end portion of the predetermined length.
- each predetermined length of the integrated tubing is a catheter tube.
- the first-end portion of the predetermined length of the integrated tubing is a distal-end portion of the catheter tube configured to interface with a patient’s anatomy.
- the second-end portion of the predetermined length of the integrated tubing is a proximal-end portion of the catheter tube configured to interface with procedural equipment or instrumentation.
- FIG. 1 illustrates a cross-section of single-lumen integrated tubing with integrated optical fiber in accordance with some embodiments.
- FIG. 2 illustrates a cross-section of two-lumen integrated tubing with integrated optical fiber in accordance with some embodiments.
- FIG. 3 A illustrates a cross-section of three-lumen integrated tubing with integrated optical fiber in accordance with some embodiments.
- FIG. 3B illustrates a cross-section of alternative three-lumen integrated tubing with integrated optical fiber in accordance with some embodiments.
- FIG. 4A illustrates a CVC including a two-lumen catheter tube with integrated optical fiber in accordance with some embodiments.
- FIG. 4B illustrates a detailed view of a proximal-end portion of a catheter tube of the CVC of FIG. 4 A.
- FIG. 5 illustrates a method of manufacturing integrated tubing with integrated optical fiber in accordance with some embodiments.
- a“proximal portion” or a“proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient.
- a“proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient.
- A“proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient.
- the proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.
- a“distal portion” or a“distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient.
- a“distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient.
- A“distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient.
- the distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.
- a tip of the PICC or CVC can move becoming displaced from an ideal position in a patient’s SVC.
- a clinician believing such a PICC or CVC has displaced typically checks for displacement by chest X-ray and replaces the PICC or CVC if necessary.
- X-rays expose patients to ionizing radiation. Therefore, there is a need for clinicians to easily and safely check for displacement of PICCs and CVCs for replacement thereof if necessary.
- FIG. 1 illustrates a cross-section of single-lumen integrated tubing 100 with integrated optical fiber 110 in accordance with some embodiments.
- FIG. 2 illustrates a cross- section of two-lumen integrated tubing 200 with the integrated optical fiber 110 in accordance with some embodiments.
- FIG. 3A illustrates a cross-section of three-lumen integrated tubing 300A with the integrated optical fiber 110 in accordance with some embodiments.
- FIG. 3B illustrates a cross-section of alternative three-lumen integrated tubing 300B with the integrated optical fiber 110 in accordance with some embodiments.
- the integrated tubing 100 includes a tubing wall 104, a lumen 102, and a longitudinal bead 106 of the integrated tubing 100 including one or more optical fibers 110 disposed therein.
- the integrated tubing 200 includes a tubing wall 104, two lumens 202a and 202b, a longitudinal bead 206 of the integrated tubing 200 including the one or more optical fibers 110 disposed therein.
- the integrated tubing 300A includes a tubing wall 104, three lumens 202, 302a, and 302b, and a longitudinal bead 306 of the integrated tubing 300 A including the one or more optical fibers 110 disposed therein.
- the integrated tubing 300B includes a tubing wall 104, three lumens 303a, 303b, and 303c, and a longitudinal bead 306 of the integrated tubing 300B including the one or more optical fibers 110 disposed therein.
- the integrated tubing disclosed herein includes at least a tubing wall, one or more lumens, and a longitudinal bead of the integrated tubing including one or more optical fibers disposed therein.
- the lumen 102 is defined at least in part by the tubing wall 104, particularly an internal surface of the tubing wall 104.
- the longitudinal bead 106 of the integrated tubing 100 is between opposing sides of the tubing wall 104.
- the longitudinal bead 106 is inside of the integrated tubing 100.
- the longitudinal bead 106 is incorporated into the tubing wall 104, particularly the internal surface of the tubing wall 104.
- the lumen 102 is further defined at least in part by the longitudinal bead 106.
- each lumen of the two lumens 202a and 202b is defined at least in part by the tubing wall 104, particularly an internal surface of the tubing wall 104.
- the integrated tubing 200 further includes a septum 208 of the integrated tubing
- Each lumen of the two lumens 202a and 202b is further defined at least in part by the septum 208.
- the septum 208 separates the integrated tubing 200 into two halves such that each lumen of the two lumens 202a and 202b of the integrated tubing 200 has approximately a same volume as the other lumen of the two lumens 202a and 202b for an arbitrary length of the integrated tubing 200.
- the septum 208 need not separate the integrated tubing 200 into two equal halves in accordance with the foregoing. For example, instead of the septum 208 extending from 3 o’clock to 9 o’clock as it would if the cross-section of the integrated tubing 200 of FIG.
- each lumen of the two lumens 202a and 202b of the integrated tubing 200 would have a different volume than the other lumen of the two lumens 202a and 202b for an arbitrary length of the integrated tubing 200.
- the longitudinal bead 206 of the integrated tubing 200 is between opposing sides of the tubing wall 104.
- the longitudinal bead 206 is inside of the integrated tubing 200.
- the longitudinal bead 206 is incorporated into the septum 208, particularly a medial portion of the septum 208 such that the longitudinal bead 206 is coaxial with a central axis of the integrated tubing 200.
- the longitudinal bead 206 can alternatively be incorporated into the septum 208 between the medial portion of the septum 208 and the tubing wall 104. That said, the longitudinal bead 206 need not be incorporated into the septum 208 at all.
- the longitudinal bead 206 can be incorporated into the tubing wall 104 like that of the integrated tubing 100. Regardless of how the longitudinal bead 206 is incorporated into the integrated tubing 200, at least one lumen of the two lumens 202a and 202b of the integrated tubing 200 is further defined at least in part by the longitudinal bead 206.
- each lumen of the three lumens 202, 302a, and 202b is defined at least in part by the tubing wall 104, particularly an internal surface of the tubing wall 104.
- the integrated tubing 300 A further includes two septa 208 and 308 of the integrated tubing 300 A.
- Each lumen of the three lumens 202, 302a, and 302b is further defined at least in part by the septum 208.
- Each lumen of the two lumens 302a and 302b is even further defined at least in part by the septum 308.
- the septum 208 separates the integrated tubing 300B into a first set of two halves
- the septum 308 separates one half of the first set of two halves into a second set of two more halves.
- each lumen of the two lumens 302a and 302b of the integrated tubing 300 A has approximately a same volume as the other lumen of the two lumens 302a and 302b for an arbitrary length of the integrated tubing 200, and the lumen 202 has at least double the volume of the two lumens 302a and 302b for the arbitrary length of the integrated tubing 200.
- the septum 208 need not separate the integrated tubing 200 into the first set of two halves and the septum 308 need not separate one half of the first set of two halves into a second set of two more halves in accordance with the foregoing.
- the septum 208 could extend from 11 o’clock to 7 o’clock.
- the septum 308 could extend from 2 o’clock to the medial portion of the septum 208 or from 2 o’clock to between the medial portion of the septum 208 and the tubing wall 104.
- each lumen of the three lumens 202, 302a, and 302b of the integrated tubing 300 A could have a different volume than another lumen of the three lumens 202, 302a, and 302b for an arbitrary length of the integrated tubing 300 A.
- the longitudinal bead 306 of the integrated tubing 300A is between opposing sides of the tubing wall 104.
- the longitudinal bead 306 is inside of the integrated tubing 300A.
- the longitudinal bead 306 is incorporated into the septa 208 and 308, particularly a medial portion of the septum 208 and an end portion of the septum 308 such that the longitudinal bead 306 is coaxial with a central axis of the integrated tubing 300 A.
- the longitudinal bead 306 can alternatively be incorporated into the septum 208 between the medial portion of the septum 208 and the tubing wall 104 or in a medial portion of the septum 308.
- the longitudinal bead 306 need not be incorporated into either septum of the septa 208 and 308 at all. Instead, the longitudinal bead 306 can be incorporated into the tubing wall 104 like that of the integrated tubing 100. Regardless of how the longitudinal bead 306 is incorporated into the integrated tubing 300 A, at least one lumen of the three lumens 202, 302a, and 302b of the integrated tubing 300A is further defined at least in part by the longitudinal bead 306.
- each lumen of the three lumens 303a, 303b, and 303c is defined at least in part by the tubing wall 104, particularly an internal surface of the tubing wall 104.
- the integrated tubing 300B further includes three septa 309a, 309b, and 309c of the integrated tubing 300B.
- Each lumen of the three lumens 303a, 303b, and 300c is further defined at least in part by two septa of the three septa 309a, 309b, and 309c.
- the three septa 309a, 309b, and 309c separate the integrated tubing 300B into thirds such that each lumen of the three lumens 303a, 303b, and 300c of the integrated tubing 300B has approximately a same volume as another lumen of the three lumens 303a, 303b, and 300c for an arbitrary length of the integrated tubing 200.
- the three septa 309a, 309b, and 309c need not separate the integrated tubing 300B into three equal thirds in accordance with the foregoing. For examples, see the integrated tubing 300A of FIG. 3 A and the related description set forth above.
- each lumen of the three lumens 303 a, 303b, and 303 c of the integrated tubing 300B could have a different volume than another lumen of the three lumens 303a, 303b, and 303c for an arbitrary length of the integrated tubing 300B.
- the longitudinal bead 306 of the integrated tubing 300B is between opposing sides of the tubing wall 104.
- the longitudinal bead 306 is inside of the integrated tubing 300B.
- the longitudinal bead 306 is incorporated into the septa 309a, 309b, and 309c, particularly an end portion of each septum of the septa 309a, 309b, and 309c such that the longitudinal bead 306 is coaxial with a central axis of the integrated tubing 300B.
- the longitudinal bead 306 can alternatively be incorporated into a medial portion of any septum of the septa 309a, 309b, and 309c.
- the longitudinal bead 306 need not be incorporated into any septum of the septa 309a, 309b, and 309c at all. Instead, the longitudinal bead 306 can be incorporated into the tubing wall 104 like that of the integrated tubing 100. Regardless of how the longitudinal bead 306 is incorporated into the integrated tubing 300B, at least one lumen of the three lumens 203a, 303b, and 303C of the integrated tubing 300B is further defined at least in part by the longitudinal bead 306.
- the integrated tubing 100, 200, 300 A, or 300B can be integrated bump tubing having a diameter that varies along its length.
- each predetermined length of the integrated bump tubing can have a first- end portion having a smaller diameter than a second-end portion such that the first-end portion of the predetermined length of the integrated bump tubing is configured to interface with, for example, mammalian anatomy and the second-end portion of the predetermined length of the integrated bump tubing is configured to interface with medical equipment or instrumentation.
- the integrated tubing 100, 200, 300 A, or 300B including the tubing wall 104, the septa 208, 308, or 309a-c, and the longitudinal bead 106, 206, or 306 is either an inorganic polymer such as silicone or an organic polymer such as polyurethane.
- the optical fiber 110 disposed in the longitudinal bead 106, 206, or 306 of the integrated tubing 100, 200, 300 A, or 300B includes one optical fiber or a bundle of two or more optical fibers of silica glass or an organic polymer, optionally cladded with cladding of another silica glass or organic polymer having a lower refractive than that of the optical fiber, a buffer coating of yet another organic polymer, or a combination thereof.
- Each optical fiber of the foregoing optical fibers has a diameter between about 8 pm and about 25 pm.
- FIG. 4 A illustrates a CVC 400 including a two-lumen catheter tube 402 with an integrated optical -fiber stylet 110 in accordance with some embodiments.
- FIG. 4B illustrates a detailed view of a proximal-end portion of the catheter tube 402 of the CVC 400 of FIG. 4A.
- FIG. 2 illustrates the cross-section of the two-lumen integrated tubing 200 with the integrated optical fiber 1 10 in accordance with some embodiments; however, the catheter tube 402 is a predetermined length of the integrated tubing 200, so features of the integrated tubing 200 are incorporated into the catheter tube 402 as set forth below.
- the CVC 400 includes the catheter tube 402, which, as set forth in more detail below, includes two catheter-tube lumens 202a and 202b, a bifurcated hub having two hub lumens correspondingly fluidly connected to the two catheter-tube lumens 202a and 202b, two extension legs, each extension leg having an extension-leg lumen fluidly connected to a hub lumen of the two hub lumens, and a Luer connector connected to each extension leg of the two extension legs.
- the CVC 400 optionally includes a stylet extension 404 extending from the hub of the CVC 400 for interfacing the integrated optical-fiber stylet 110 of the catheter tube 402 with procedural equipment or instrumentation.
- the stylet extension 404 can be a skived portion of the catheter tube 402 including the optical -fiber stylet 110 or the skived portion of the catheter tube 402 disposed in another tube (e.g., an extension tube).
- each lumen of the two catheter-tube lumens 202a and 202b is defined at least in part by a catheter-tube wall 104, particularly an internal surface of the catheter-tube wall 104.
- the catheter tube 402 further includes a septum 208 of the catheter tube 402.
- Each lumen of the two catheter-tube lumens 202a and 202b is further defined at least in part by the septum 208.
- the septum 208 separates the catheter tube 402 into two halves such that each lumen of the two catheter-tube lumens 202a and 202b of the catheter tube 402 has approximately a same volume as the other lumen of the two catheter-tube lumens 202a and 202b for an arbitrary length of the catheter tube 402.
- the septum 208 need not separate the catheter tube 402 into two equal halves in accordance with the foregoing. For example, instead of the septum 208 extending from 3 o’clock to 9 o’clock as it would if the cross-section of the catheter tube 402 of FIG.
- each lumen of the two catheter-tube lumens 202a and 202b of the catheter tube 402 would have a different volume than the other lumen of the two catheter-tube lumens 202a and 202b for an arbitrary length of the catheter tube 402.
- a longitudinal bead 206 of the catheter tube 402 in which the integrated optical- fiber stylet 110 is disposed is between opposing sides of the catheter-tube wall 104.
- the longitudinal bead 206 is inside of the catheter tube 402.
- the longitudinal bead 206 is incorporated into the septum 208, particularly a medial portion of the septum 208 such that the longitudinal bead 206 is coaxial with a central axis of the catheter tube 402.
- the longitudinal bead 206 can alternatively be incorporated into the septum 208 between the medial portion of the septum 208 and the catheter-tube wall 104. That said, the longitudinal bead 206 need not be incorporated into the septum 208 at all.
- the longitudinal bead 206 can be incorporated into the catheter-tube wall 104 like that of the integrated tubing 100. Regardless of how the longitudinal bead 206 is incorporated into the catheter tube 402, at least one lumen of the two catheter-tube lumens 202a and 202b of the catheter tube 402 is further defined at least in part by the longitudinal bead 206.
- the catheter tube 402 is a predetermined length of the integrated tubing 200 cut such that a distal-end portion of the catheter tube 402 has a smaller diameter than a proximal- end portion of the catheter tube 402.
- the distal-end portion of the catheter tube 402 is configured to interface with a patient’s anatomy.
- the proximal-end portion of the catheter tube 402 is configured to interface with procedural equipment or instrumentation.
- the catheter tube 402 including the catheter-tube wall 104, the septum 208, and the longitudinal bead 206 is either an inorganic polymer such as silicone or an organic polymer such as polyurethane.
- the integrated optical-fiber stylet 110 disposed in the longitudinal bead 206 of the catheter tube 402 includes one optical fiber or a bundle of two or more optical fibers of silica glass or an organic polymer, optionally cladded with cladding of another silica glass or organic polymer having a lower refractive than that of the optical fiber, a buffer coating of yet another organic polymer, or a combination thereof.
- Each optical fiber of the foregoing optical fibers has a diameter between about 8 pm and about 25 pm.
- CVC 400 set forth above is a two-lumen CVC having the two-lumen catheter tube 402
- other medical devices are possible such as a two-lumen PICC analogous to the CVC 400.
- one- or three-lumen CVCs or PICCs are possible, wherein each one- lumen CVC or PICC has a catheter tube and integrated optical -fiber stylet 110 corresponding to the integrated tubing 100, and wherein each three-lumen CVC or PICC has a catheter tube and integrated optical-fiber stylet 110 corresponding to the integrated tubing 300A or 300B.
- FIG. 5 illustrates a method of manufacturing the integrated tubing 100, 200,
- a method for manufacturing the integrated tubing 100, 200, 300A, or 300B includes threading the optical fiber 110 (e.g., one-by-one or from a spool of the optical fiber) through a die 502 of an extruder 500; forcing a molten polymeric material 504 such as silicone or polyurethane through the die 502 around the optical fiber 110 to form the integrated tubing 100, 200, 300A, or 300B with the optical fiber 110 disposed within the longitudinal bead 106, 206, or 306 of the integrated tubing 100, 200, 300 A, or 300B; and cooling the integrated tubing 100, 200, 300 A, or 300B in a cooling bath by pulling the integrated tubing through the cooling bath with a puller.
- the optical fiber 110 e.g., one-by-one or from a spool of the optical fiber
- a molten polymeric material 504 such as silicone or polyurethane
- a rate of pulling the integrated tubing 100, 200, 300 A, or 300B with the puller is increased to create portions of the integrated tubing 100, 200, 300A, or 300B with a smaller diameter or decreased to create portions of the integrated tubing 100, 200, 300 A, or 300B with a larger diameter.
- the method can further include coiling the integrated tubing 100, 200, 300 A, or
- the method can further include cutting the integrated tubing 100, 200, 300 A, or
- each predetermined length of the integrated tubing 100, 200, 300 A, or 300B can be a catheter tube such as the catheter tube 402 formed of a predetermined length of the integrated tubing 200.
- the first-end portion of such a predetermined length of the integrated tubing 200 is a distal-end portion of the catheter tube 402 configured to interface with a patient’s anatomy.
- the second-end portion of such a predetermined length of the integrated tubing 200 is a proximal-end portion of the catheter tube 402 configured to interface with procedural equipment or instrumentation.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
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- Mechanical Engineering (AREA)
- Heart & Thoracic Surgery (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Pulmonology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Surgery (AREA)
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- Pathology (AREA)
- Molecular Biology (AREA)
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- Optics & Photonics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Manufacturing & Machinery (AREA)
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- Media Introduction/Drainage Providing Device (AREA)
- Optical Fibers, Optical Fiber Cores, And Optical Fiber Bundles (AREA)
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
MX2021016146A MX2021016146A (es) | 2019-07-12 | 2020-07-10 | Tubería con fibra óptica integrada, dispositivos médicos y métodos de los mismos. |
KR1020227004044A KR20220035410A (ko) | 2019-07-12 | 2020-07-10 | 광섬유가 일체화된 배관, 의료 장치, 및 그 방법(tubing with integrated optical fiber, medical devices, and methods thereof) |
AU2020314561A AU2020314561A1 (en) | 2019-07-12 | 2020-07-10 | Tubing with integrated optical fiber, medical devices, and methods thereof |
JP2021575477A JP2022539686A (ja) | 2019-07-12 | 2020-07-10 | 統合型光ファイバを有するチューブ、医療機器、およびその方法 |
BR112021026633A BR112021026633A2 (pt) | 2019-07-12 | 2020-07-10 | Tubulação com fibra óptica integrada, dispositivos médicos, e métodos dos mesmos |
EP20840203.2A EP3996789A4 (de) | 2019-07-12 | 2020-07-10 | Schlauch mit integrierter glasfaser, medizinprodukte und verfahren dafür |
CA3146654A CA3146654A1 (en) | 2019-07-12 | 2020-07-10 | Tubing with integrated optical fiber, medical devices, and methods thereof |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201962873794P | 2019-07-12 | 2019-07-12 | |
US62/873,794 | 2019-07-12 |
Publications (1)
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WO2021011408A1 true WO2021011408A1 (en) | 2021-01-21 |
Family
ID=74058693
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2020/041692 WO2021011408A1 (en) | 2019-07-12 | 2020-07-10 | Tubing with integrated optical fiber, medical devices, and methods thereof |
Country Status (10)
Country | Link |
---|---|
US (1) | US20210007592A1 (de) |
EP (1) | EP3996789A4 (de) |
JP (1) | JP2022539686A (de) |
KR (1) | KR20220035410A (de) |
CN (2) | CN112206401A (de) |
AU (1) | AU2020314561A1 (de) |
BR (1) | BR112021026633A2 (de) |
CA (1) | CA3146654A1 (de) |
MX (1) | MX2021016146A (de) |
WO (1) | WO2021011408A1 (de) |
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US20150306805A1 (en) * | 2014-04-25 | 2015-10-29 | Medtronic Ablation Frontiers Llc | Methods of manufacturing a multi-lumen device |
US20160158492A1 (en) * | 2014-12-09 | 2016-06-09 | Tephratech LLC | Partially shrinkable tubing with multiple lumens and associated methods |
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US8585858B2 (en) * | 2011-06-06 | 2013-11-19 | Alex M. Kronfeld | Medical catheter with bump tubing proximal segment |
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2020
- 2020-07-10 BR BR112021026633A patent/BR112021026633A2/pt unknown
- 2020-07-10 KR KR1020227004044A patent/KR20220035410A/ko unknown
- 2020-07-10 US US16/926,414 patent/US20210007592A1/en active Pending
- 2020-07-10 WO PCT/US2020/041692 patent/WO2021011408A1/en unknown
- 2020-07-10 MX MX2021016146A patent/MX2021016146A/es unknown
- 2020-07-10 AU AU2020314561A patent/AU2020314561A1/en active Pending
- 2020-07-10 JP JP2021575477A patent/JP2022539686A/ja active Pending
- 2020-07-10 CN CN202010663528.2A patent/CN112206401A/zh active Pending
- 2020-07-10 CN CN202021358780.4U patent/CN212756809U/zh active Active
- 2020-07-10 EP EP20840203.2A patent/EP3996789A4/de active Pending
- 2020-07-10 CA CA3146654A patent/CA3146654A1/en active Pending
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US6966889B2 (en) * | 1992-08-13 | 2005-11-22 | Saab Mark A | Multi-lumen catheters and methods for using same |
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US6652565B1 (en) * | 1998-04-21 | 2003-11-25 | Alsius Corporation | Central venous catheter with heat exchange properties |
US20020077593A1 (en) | 1999-10-21 | 2002-06-20 | Pulmonx | Apparatus and method for isolated lung access |
US7186222B1 (en) * | 2002-09-10 | 2007-03-06 | Radiant Medical, Inc. | Vascular introducer with temperature monitoring probe and systems for endovascular temperature control |
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US20140012193A1 (en) | 2012-07-05 | 2014-01-09 | Hua QIU | Catheter with a dual lumen monolithic shaft |
US20140046174A1 (en) * | 2012-08-07 | 2014-02-13 | Covidien Lp | Microwave ablation catheter and method of utilizing the same |
US20150306805A1 (en) * | 2014-04-25 | 2015-10-29 | Medtronic Ablation Frontiers Llc | Methods of manufacturing a multi-lumen device |
US20160158492A1 (en) * | 2014-12-09 | 2016-06-09 | Tephratech LLC | Partially shrinkable tubing with multiple lumens and associated methods |
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See also references of EP3996789A4 |
Also Published As
Publication number | Publication date |
---|---|
JP2022539686A (ja) | 2022-09-13 |
CN212756809U (zh) | 2021-03-23 |
MX2021016146A (es) | 2022-08-02 |
US20210007592A1 (en) | 2021-01-14 |
CA3146654A1 (en) | 2021-01-21 |
EP3996789A1 (de) | 2022-05-18 |
BR112021026633A2 (pt) | 2022-02-15 |
CN112206401A (zh) | 2021-01-12 |
KR20220035410A (ko) | 2022-03-22 |
EP3996789A4 (de) | 2023-08-23 |
AU2020314561A1 (en) | 2022-01-27 |
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